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Considerations should be made in regard to social media and clinical trials. Public use and disclosure of an invention before filing for a patent can invalidate the claims and locating evidence to demonstrate public use of an invention can be challenging, particularly if the use is not commercial or publicized.
In this day and age, it seems as if all information ends up on the Internet. Clinical trials are no exception. Announcements of the trials and protocols are published on the web. Patients chat about their experiences in chat rooms. They may post their participation and progress on Facebook, tweet on recent results on Twitter and chronicle their progress on blogs. What does this mean for patent protection?
In life sciences technology – pharmaceuticals, diagnostic tests and medical devices – clinical trials may occur before a complete portfolio of patents has been filed covering all aspects of the invention. For example, a company may have filed patents on the chemical structure of a drug and its use to treat one disease. However, patents on additional discovered uses of the drug, new modes of administration and combinations with other treatments are often filed at a later time. These later applications may come about as clinical trials are performed and new data becomes available.
Public use and disclosure of an invention before filing for a patent can invalidate the claims. Generally, when the public use occurs more than one year before the effective filing date, this use acts as anticipatory prior art under 35 U.S.C. §102. However, locating evidence to demonstrate public use of an invention can be challenging, particularly if the use is not commercial or publicized.
Clinical trials may be performed under confidentiality restrictions. Generally, healthcare providers participating in the trials sign agreements limiting the information that can be accessed and disclosed. It is less frequent that the trial participants sign a similar agreement. But while these participants have access to certain data such as the drug administered, dose and perhaps, their individual results, finding evidence of this knowledge and its disclosure to others was difficult in the past. The information generally remained with a very limited group of people – likely the participant, the associated healthcare giver and perhaps a few relatives or friends.
Now, however, in the digital age, websites along with Twitter, Facebook, and many other social media apps play a major role in the distribution and memorialization of information to a wide audience. The availability of this information with a few keyboard clicks and searches may provide an avenue to readily gather information. The combination of posted clinical trial protocols and patient experiences can provide evidence for an invalidity challenge.
One other area where internet disclosures may play a role is off-label use, where a physician prescribes a drug for a use not yet approved by the FDA. These may be isolated incidents. Yet the patient may choose to post about the experience including details such as the drug administered, the dose, specific instructions for administration and its effects on disease symptoms and side effects.
In the past, some courts have declined to find public use where only a few relatively uninformed people learned of the use such as through one-on-one communication with friend or colleagues. However, dissemination to a wide internet audience on a website dedicated to discussions of a specific disease could be viewed differently. Additionally, these tangible records of patient experiences may also qualify as printed publications rendering the claims anticipated or obvious under the patent statutes.
So what’s the fix? Given that there may be ethical and medical concerns with restricting patients’ ability to speak about their medical care, their symptoms and results, steps taken on the sponsor’s end of things may be easier. Having a patent portfolio strategy in place can help ensure protection down the road.
When to file
Filing a patent application prior to the clinical trial is likely the optimal solution. There is a one-year “grace period” for public use allowing time between the use of the invention and the filing of an application. The recent America Invents Act (AIA) created two categories with respect to the grace-period rules. For pre-AIA patents, the one-year grace period encompasses the year before the filing date of the earliest application filed in the US. For patents filed after the operable AIA date (on or after March 16, 2013), the grace period starts one year before the filing of any application, US and foreign, that provides the benefit of priority for the claimed invention. Thus, depending on where applications have been filed, the grace period clock may start ticking earlier for post-AIA patents.
Also keep in mind that the AIA changed the rules as to the “where” of a public use. For pre-AIA patents, only public use in the US could be used to invalidate the claims. Many clinical trials are done outside the US. For patents subject to AIA, the public use need not occur in the US – public use can be anywhere in the world. Foreign-based clinical trials can now be used as prior art against a US patent application.
While early patent filing is ideal, in some circumstances there may not be enough data or facts known before the trial begins or even concludes to craft the full scope of patent claims. One or more provisional patent applications can be filed as a “place-holder” and then more information can be added throughout the year before the non-provisional patent filing date comes due.
In some circumstances, a clinical trial, particularly in the earlier stages of drug development, may not constitute a public use. For example, trials comparing and testing variants of a drug, different methods of administration or a variety of formulations may fall under the “experimental use” exception. This exception permits testing the claimed features of the invention and determining if the invention will work for its intended purpose. The aim of such testing must be for the patent filing, rather than simply for commercial purposes. A laundry list of factors guides the determination of whether the testing is “experimental.” Some of these factors are the necessity for public nature of the test, the amount of control and monitoring of the test by the inventor, the time period of the test and whether any confidentiality obligations applied. But note that the experimental use exception, while shielding it from invalidity under a public use theory, does not inoculate the claims against invalidity based on public disclosure of the invention.
Patent claims susceptible to public use challenges
Method claims may be more at risk than composition claims for disclosure through social media and websites. Generally, patients are not provided the chemical structure of the active ingredients or the elements of the pharmaceutical formulation. However, they may have access to other information – such as the dosage amounts, timing and frequency of administration, and additional factors such as taking the drug with meals, while fasting or along with an additional supplement such as a vitamin or aspirin. These details may find their way onto conversation strings in chat sites or Facebook posts, along with a description of the patient’s results and side effects.
Consider a claiming strategy that includes features of the drug or its administration that are not disclosed to the trial participants. This may include the chemical structure of the drug and formulation ingredients and their proportions. Keep in mind, however, that if the chemical structure of the drug is already publicly known prior to the clinical trial, this knowledge combined with its use in a trial for a new disease or with a different formulation may render some claims obvious.
On the flip side, for those hoping to gather evidence in support of a patent challenge, simply the discovery of a website or post about a clinical trial may not be sufficient. For a reference to be anticipatory, it must disclose all elements of the claimed invention. For example, postings that mention a clinical trial of a drug by name of code number may lack a necessary disclosure for a claimed element such as the chemical structure or its formulation. Authentication of the information on the site, particularly as to what content was present prior to the filing of the patent in question can present a significant hurdle. Some courts as well as the Patent Trials and Appeals Board have accepted date stamped evidence from the Internet Archive Wayback Machine as printed prior art. These archived versions, however, may not have the full disclosure that appears in the current posting, and thus fail to disclose all of the claimed elements prior to the filing date of the patent.
Disclosure of information in connection with clinical trials will remain a balance between confidentiality and the necessity to provide sufficient information to patients and their healthcare providers for informed consent and proper medical care. Patent portfolio strategy should take as a given that patients will disclose the trial information and results on websites and social media.
Strategies to protect drugs and their methods of use should therefore keep in mind these risks, and seek to minimize the scope and content of any disclosures before patent applications are filed.
Erica Pascal, PhD, is a partner in DLA Piper’s Patent Litigation practice.